Associate Director, Tech Transfer & Lifecycle Lead

About the role

Lonza is hiring an Associate Director, Tech Transfer & Lifecycle Lead (80-100% site-based) in Stein, Switzerland, to own critical customer programs in its Drug Product fill & finish manufacturing facility. The role leads technology transfers, commercial launches and lifecycle management, defines validation strategies and sets manufacturing standards, working in cross-functional teams. Relocation assistance is available for eligible candidates and their families.

Key responsibilities

• Lead high-value Drug Product technology transfer and lifecycle programs from clinical development through process validation (PPQ), regulatory submission, commercialization, CPV/OPV and lifecycle management.
• Act as senior technical authority for complex customer programs, defining commercialization and validation strategies and serving as escalation point for manufacturing, process and compliance issues.
• Lead transfer, scale-up and implementation of manufacturing processes into GMP operations, ensuring manufacturing readiness and routine production performance.
• Develop and oversee Stage 1, 2 and 3 process validation strategies, including risk assessments, PPQ execution, statistical evaluations, trend analysis and post-approval change assessments.
• Partner with customers and stakeholders across Manufacturing, MSAT, QA, QC, Regulatory Affairs and Supply Chain to deliver milestones, support regulatory submissions and prepare for PAI and GMP audits.
• Mentor Technology Transfer Leads and MSAT experts and drive harmonization of SOPs, validation standards and lifecycle management processes.

Required profile

• Extensive experience in biopharma, pharma or CDMO environments, with expertise in Drug Product technology transfer, process validation and lifecycle management in aseptic fill & finish.
• Demonstrated success leading complex technology transfer and commercial launch programs and influencing cross-functional stakeholders.
• Excellent communication, stakeholder management and leadership skills, with the ability to mentor technical teams.

Required skills

• Aseptic processing, including biologics, lyophilization, prefilled syringes, sterilization and primary packaging.
• GMP, CMC and global regulatory requirements.
• Stage 1, 2 and 3 process validation, PPQ, CPV/OPV, statistical data analysis and continuous process improvement.

What we offer

• An agile career and dynamic working culture in an inclusive workplace.
• Compensation programs recognizing high performance and benefits depending on role and location.
• Relocation assistance for eligible candidates and their families.